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SAPHIR : Assessment of Predictive Factors for Persistence of Treatment After Initiation of Adalimumab With a Biosimilar (Adalimumab Fresenius KaBI or Substitution of Reference Adalimumab With the Fresenius Kabi Adalimumab Biosimilar in Patients With Chronic Inflammatory Diseases

Recruiting
18 years of age
Both
Phase N/A

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Overview

A prospective, longitudinal, multicentre, observational cohort follow-up study conducted in France.

Description

In a population of adult patients who are targeted to initiate adalimumab or previously treated with Humira® to get switched to a biosimilar (FK adalimumab) and followed up for a period of 12 months under routine medical practice conditions.

  • Primary objective: to define predictive factors for the persistence of treatment
  • Secondary objectives:
  • To assess the therapeutic benefit and the tolerability of the treatment
  • To describe the reasons for treatment discontinuations occurring during follow-up

Eligibility

Inclusion Criteria:

  • Patient aged 18 years or over
  • Patient who have been informed of the objectives and the conditions of the study and who did not object to its participation
  • Patient diagnosed with one chronic inflammatory rheumatological (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) or chronic inflammatory bowel (Crohn's disease, ulcerative colitis) diseases
  • Patient for whom the investigator has decided, with patient's agreement and prior to
    inclusion
  • Or to initiate adalimumab by prescribing a biosimilar (Adalimumab FK)
  • Either to replace Humira® with a biosimilar (AdalimumabFK)

Exclusion Criteria:

  • Patient enrolled in an interventional therapeutic trial at the time of inclusion
  • Patient refusing or unable to comply with the study follow-up procedures (patient not contactable by telephone, unable to complete the self-administered questionnaire, or having poor French language skills, etc.)

Study details

Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

NCT05598684

Fresenius Kabi, France

16 June 2024

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